(40 days)
The indication for use of the Corix 70 Plus-USV (with DPM timer) is extra oral The melodelen for use in dentistry as required for the radiographic examination and diagnosis of the dental anatomy.
Corix 70 Plus-USV is a Dental X-Ray generator; its primary use is for intra oral image receptor radiology. For such application, a peak voltage of 70 kVp has been demonstrated to give a high quality film with a good film quality/risk ratio. This is also enhanced by the fact that the tube current has the value of 8 mA, assuring effectiveness. The soft X-Ray are filtered by the inherent filtration and by an additional filter to guarantee the minimum 2 mm eq. of Al required by specifications. Exposure times are microprocessor controlled, assuring a high constancy and also repeatability. The high voltage generator is enclosed in a cover. The beam-limiting device is formed by a circular cone with a maximum diameter of 60 mm. The weight of the tubehead is 7.5 kg. The certified components may be assembled in different configurations in terms of arms and mounting. The control box assembly and the timer are combined as one and include all the electronics to power the high voltage transformer contained on the tubehead. plastic prismatic cover. X-Ray exposures are signaled by both acoustic and optical signals. The operator may choose exposure times ranging from 0.03 up to 3.00 seconds.
This is a 510(k) summary for a dental X-ray generator, the Corix 70 Plus-USV. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, the Explor-X 70. The provided document does not contain information about a study that assesses the device's performance against specific acceptance criteria relevant to AI/ML or diagnostic accuracy.
The summary primarily focuses on the technical specifications and intended use of the device, comparing them to a predicate device to establish substantial equivalence.
Therefore, many of the requested sections below cannot be populated as the provided text does not contain that information.
1. A table of acceptance criteria and the reported device performance
Based on the provided K031802 510(k) summary, the acceptance criteria are based on demonstrating substantial equivalence to a predicate device by comparing technical characteristics and intended use. Performance in terms of diagnostic accuracy (which would typically involve measures like sensitivity, specificity, AUC) is not assessed or reported for this type of device in this document.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Corix 70 Plus-USV) |
|---|---|
| Intended Use substantially equivalent to predicate | Extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth (Identical to predicate) |
| High Voltage value ($kV_p$) equivalent to predicate | 70 $kV_p$ (Identical to predicate) |
| Tube current (mA) equivalent to predicate | 8 mA (Identical to predicate) |
| X-Ray exposure time control method equivalent | Microprocessor Controlled (Identical to predicate) |
| Line Voltage Fluctuations compensation method equivalent | Automatically by software (Identical to predicate) |
| Safety features equivalent or better | Dead man command, Safety backup timer (Identical/Equivalent to predicate) |
| Signaling devices equivalent or better | Acoustic and visual signal, Optional remote signaling (Identical/Equivalent to predicate) |
| Overall functionality and technology similar | "The functionality and technology are similar" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) summary for a conventional dental X-ray generator does not describe a performance study involving a test set of data for diagnostic accuracy or AI/ML evaluation. It focuses on engineering specifications and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No diagnostic performance study for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No diagnostic performance study for a test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a conventional dental X-ray generator, not an AI/ML device. Therefore, no MRMC study for AI assistance was conducted or would be relevant for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a conventional dental X-ray generator, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No diagnostic performance study is described. The "ground truth" for this submission is related to engineering standards, safety regulations, and establishing substantial equivalence based on technical specifications and intended use.
8. The sample size for the training set
Not applicable. This is a conventional dental X-ray generator and does not involve AI/ML or a training set.
9. How the ground truth for the training set was established
Not applicable. This is a conventional dental X-ray generator and does not involve AI/ML or a training set.
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KO3180Z
510K Summary
| Date: | April 21, 2003 |
|---|---|
| Applicant | Coramex S.A.Lauro Villar 94-B02440 - Mexico, D.F. MexicoRegistration Number: 9613804 |
| Contact Person | Massimo Bachi - President |
| Telephone (Applicant) | 011-52-55-5394-1192 |
| Device Name: | Corix 70 Plus-USV |
| Common Name: | X-Ray |
| Classification Name: | Unit, X-Ray, Extraoral |
| Legally Marketed device to which firm isclaiming equivalence: | Explor-X 70 |
| Description of the Device: | Corix 70 Plus-USV is a Dental X-Raygenerator; its primary use is for intra oralimage receptor radiology. For suchapplication, a peak voltage of 70 kVp hasbeen demonstrated to give a high qualityfilm with a good film quality/risk ratio.This is also enhanced by the fact that thetube current has the value of 8 mA,assuring effectiveness.The soft X-Ray are filtered by the inherentfiltration and by an additional filter toguarantee the minimum 2 mm eq. of Alrequired by specifications.Exposure times are microprocessorcontrolled, assuring a high constancy andalso repeatability.The high voltage generator is enclosed in acover. The beam-limiting device is formedby a circular cone with a maximumdiameter of 60 mm. The weight of thetubehead is 7.5 kg. The certifiedcomponents may be assembled in differentconfigurations in terms of arms andmounting.The control box assembly and the timer arecombined as one and include all theelectronics to power the high voltagetransformer contained on the tubehead. |
| plastic prismatic cover. X-Ray exposuresare signaled by both acoustic and opticalsignals. The operator may choose exposuretimes ranging from 0.03 up to 3.00seconds. | |
| Intended use of the device: | Corix 70 Plus-USV is an extra oral sourceX-ray system for dental radiographicexamination and diagnosis of diseases ofthe teeth. |
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Summary of the Technological characteristics of Corix 70 Plus-USV compared to the predicate device Explor-X 70.
| Explor-X 70 | Corix 70 Plus-USV | |
|---|---|---|
| Intended Use | Extra oral source X-raysystem for dentalradiographic examinationand diagnosis of diseases ofthe teeth | Extra oral source X-raysystem for dentalradiographic examinationand diagnosis of diseases ofthe teeth |
| High Voltage value | $70 kV_p$ | $70 kV_p$ |
| Tube current | 8 mA | 8 mA |
| Tube insert | CEI OCX 70-G | CEI OX/ 70-P |
| H.V. type: | Single phase, self rectifying | Single phase, self rectifying |
| X-Ray exposure time control | Microprocessor Controlled | Microprocessor Controlled |
| Compensation of LineVoltage Fluctuations | Automatically by software | Automatically by software |
| Safety features | Dead man commandSafety backup timer | Dead man commandSafety backup timer Safetybackup timer |
| Signaling devices | Acoustic and visual signalOptional remote signaling | Acoustic and visual signalOptional remote signaling |
The main differences of the Corix 70 Plus-USV with respect to the SE device are mainly aesthetics. The functionality and technology are simi!ar
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2003
Coramex S.A. % Mr. Al Sosa Chicago X-Ray Systems, Imc. 251 E. Dundee Road, Suite # 6 WHEELING IL 60090
Re: K031802
Trade/Device Name: Corix 70 Plus-USV Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: April 21, 2003
Received: June 13, 2003
Dear Mr. Sosa:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
to proceed to the market.
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510 (k) NUMBER: K031802 Corix 70 Plus-USV DEVICE NAME: INDICATIONS FOR USE:
The indication for use of the Corix 70 Plus-USV (with DPM timer) is extra oral The melodelen for use in dentistry as required for the radiographic examination and diagnosis of the dental anatomy.
(PLEASE DO NOT WRITE BELOW-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter-Use(Optional Formay 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K031802 |
|---|---|
| --------------- | --------- |
2- 3
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.